The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms of Anxiety and Depression in Adolescents With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Home Exercise Compliance
研究概览
简要总结
This study explores the effects of an eight-week exercise intervention for adolescents with Down syndrome on home exercise compliance. As well, to observe changes in fitness including muscular strength, endurance and aerobic capacity. Finally to observe any changes in mood, behavior and quality of life.
详细描述
Adolescents with Down syndrome will participate in an eight-week, center-based exercise intervention. Participants will undergo an hour of exercise intervention each week. During this time, participants will be working with a team consisting of a physician, physical therapy student volunteers, and clinical research coordinators. Exercises will focus on strength and endurance of all major muscle groups, while ensuring proper technique and form is used. They will also receive instruction on how to continue the exercise program at home.
Prior to starting, and at the end of eight sessions, all exercise participants will undergo testing procedures for anthropometric, strength and flexibility measurements. This data will be collected as part of clinically evaluating the impact of the program on each participant. In addition to the exercise program (and clinical assessments of fitness), DSFit participants will complete study measures of behavioral functioning as well as scales of depression and anxiety. Participants in the DSFit study will also complete a weekly exercise log during the intervention and for a follow-up period afterwards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •10 to 17 years old (until 18th birthday)
- •Diagnosed with Down syndrome by a physician
- •Medically cleared to exercise
排除标准
- •Requires consistent one-on-one care
- •History of behavioral issues (outbursts, aggressive/self-injurious, bolting)
- •Pre-existing cardiovascular, respiratory or orthopedic conditions that could place participant at risk for injury or illness resulting from exercise. For example:
- •Untreated significant atlantoaxial instability
- •Severe pulmonary hypertension
结局指标
主要结局
Home Exercise Compliance
时间窗: 2 months post completion of the exercise program
To establish if the participant is performing the same amount of exercise each week, for up to three months after the stopped visiting the group exercise sessions.
次要结局
- Muscular strength & endurance(The test will be performed before the exercise intervention and then after 8 weeks of exercise intervention.)
- Aerobic capacity(The test will be preformed before the exercise intervention and then after 8 weeks of exercise intervention.)
- Anxiety and Depression Symptoms(The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.)
- Behavioral Symptoms(The scale will be given the before the exercise intervention begins and then after 8 weeks of exercise intervention.)
研究者
Emily Jean Davidson, MD, MPH
Doctor
Boston Children's Hospital